Delhi High Court quashes ban on sale of Oxytocin by private drug makers

Delhi High Court quashes ban on sale of Oxytocin by private drug makers
- December 17, 2018
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The Delhi High Court on Friday quashed the Health Ministry’s ban on the sale of Oxytocin by private players on the grounds that the government did not have scientific basis for banning the drug and it also did not consider the dangers to the users of the drug by this ban. In a 100 page petition Justice S Ravindra Bhat and A Chawla noted that it is both unreasonable and arbitrary; the Union of India did not adequately weigh in the danger to the users of Oxytocin, nor consider the deleterious effect to the public generally and women particularly, of possible restricted supply if manufacture is confined to one unit. Oxytocin is used to induce labour in pregnant women and stall postpartum bleeding which is a leading cause of maternal deaths. India is one of the country’s with the highest rates of maternal mortality in the world.

However in June this year the Health Ministry following a Himachal Pradesh court directive decided to ban the manufacture of this drug by private private players on the grounds that the drug was misused to increase milk production in cattle. The Health Ministry in its directive allowed only Karnataka Antibiotics Limited to manufacture the drug, under section 26(a) of the Drugs and Cosmetics Act (D&C). This act empowers the government to prohibit manufacture of drugs and cosmetic in public interest. But drug makers PfizerNSE -0.42 %, Mylan along with activist group All India Drugs Action Network (AIDAN) took the government to court challenging the ban arguing that there was no scientific evidence to prove that the drug was harmful or misused.

A potentially life saving drug to pregnant women and young mothers, the Delhi HC said that it is hard to accept that Oxytocin is risky to human or even animal life. The drug is strongly recommended by the WHO as the choice pharmaceutical, injected at the time of human childbirth”, the Delhi HC noted. According to the own admission of the health ministry and the Central Drugs Standard Control Organisation (CDSCO), Oxytocin has been recognised as having medical use for induction and augmentation of labour, to control postpartum bleeding. The court also pointed out that the Drugs Consultative Committee from 2012 to 2018 have consistently noted that the drug has a “definite role in the medical field for both humans and animals and as such the legitimate manufacture and sale of drugs cannot be stopped”.